Regulatory Compliance and Validation Services
Regulatory ComplianceKnowledge ManagementRisk ManagementWorkforce Enhancement

Our Professional Services

Pharma-Bio Serv offers solutions to the Medical Devices, Pharmaceuticals, Biotehnology/Life Sciences, Active Pharmaceutical Ingredients, Cosmetics, Consumer Products, Food & Beverage, Retail, Government, Insurance and Banking Industries by providing a comprehensive range of services to our clients, to ensure Regulatory Compliance.
 
We are leaders in Quality Risk Management and have real life project experience in the successful implementation of QRM Strategies.
 
Our support for customers is through-out the product lifecycle:
 
  • R&D Studies
  • NDA Documentation and Filings
  • PAI Readiness
  • Audit & Inspection Preparation, Management and Response
  • Post Approval
  • Quality Systems
  • Technology Transfer
  • Validation
  • Manufacturing Controls & Process Support

We are your partner in cGMP compliance through all stages of manufacturing, supplemented with training. Once product has been transferred to manufacturing, we support the manufacturing processes to maintain state of control by implementing the latest standards such as Validation Guidance, ICH Guidelines, Process Excellence and Risk Management tools.
 
Our Services are in accordance with the latest FDA, European Medicines Agency and other international agency regulations and guidelines. All our services are founded on a Philosophy of Excellence through our personalized hands-on experience and our trained resources.
 
All work performed is properly recorded through high quality documentation. We strongly enforce, and give due attention to, documentation quality and accuracy in line with cGMP requirements.

Our Differentiators:
Sustainable Long Term Customer Relationships
•Delivering Innovation and Cost Reduction results (Competitive Focus)
•Implementing Quality Risk Management Initiatives
•Delivering tangible results through Experience and Risk Based CQV
•Providing Full Product Life-Cycle Solutions (A single outsource alternative)


Our People / Our Culture

•Expert Consultants & Trainers from Relevant Industries
•Our resources are Highly Skilled, Flexible, Client driven and customer focused
•Main Pillar ~ Code of Ethics & Business Conduct


Global Presence, Local Services

•Ability to do global strategic rollouts; leverage on expertise
•Ability to work locally

​FDA Regulated Company
•Apply PBSV services to our own Laboratory Operations
•“Practice what we preach” approach
•SOX Compliant, FDA registered, EMA inspected, and ISO Certified Lab
•We are a public company (Ticker Symbol: PBSV)

Service List

​Chemical and Microbiology Laboratory Support Process / Packaging Services​
Commissioning, Qualification and Validation ​Project Management
Computer Systems Validation​ Regulatory Compliance
​EHS Services ​Risk Management
Engineering Services ​Technical Documentation
Equipment Rental​ Technology Transfer
Information Technology and Management Services ​Training / Seminars
Placement, Staffing and Recruiting​
 
 
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